ACTRN12612000848808终止2 期
A Phase II study assessing the complete remission rate and overall survival of older patients with acute myeloid leukaemia and high risk myelodysplastic syndrome that undergo less intensive treatment
Australasian Leukaemia and Lymphoma Group0 个研究点目标入组 60 人开始时间: 2012年8月13日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 60 Years 至 o limit（—）
- 性别
- All
入选标准
- •1.Acute myeloid leukaemia (except Acute Promyelocytic Leukaemia) as defined by the WHO Classification. This can be any type of de novo or secondary AML – or high risk Myelodysplastic Syndrome (greater than 10% blasts, RAEB-2). MDS patients who have received azacitidine are not eligible for this trial, but patients with less than 10% who have failed a demethyation agent and developed AML may enter the trial.
- •2.Over the age of 60
- •3.Given written informed consent.
- •For the AC220 (quizartinib), tosedostat and ganetespib interventions:
- •4.Cardiac criteria must be met
- •5.Electrolyte levels of Potassium, Magnesium and Calcium (adjusted) must be within the institutional normal range
- •Male patients must use an effective barrier method of contraception if sexually active with a female of child-bearing potential.
排除标准
- •1.Less than 60 years of age
- •2.Previously received cytotoxic chemotherapy for AML (hydroxycarbamide, or similar low-dose therapy, to control the white count is not an exclusion criterion. Previous treatment with a demethylating agent for MDS less than 10% blasts is not an exclusion).
- •3.Blast transformation of chronic myeloid leukaemia (CML)
- •4.Concurrent active malignancy under treatment
- •5.Pregnant or lactating
- •6.Acute Promyelocytic Leukaemia
- •7.Known infection with human immunodeficiency virus (HIV)
- •8.Total bilirubin greater than or equal to 1.5 x ULN, unless due to Gilbert’s syndrome
- •9.Aspartate aminotransferase (AST) greater than or equal to 2.5 x UL and/or alkaline phosphatase greater than or equal to 2.5 x ULN
- •10.Serum creatinine greater than or equal to 175µmol/L
- •11.History of myocardial infarction (MI), unstable angina, cerebrovascular accident, or transient ischemic attack (CVA/TIA) within 6 months
- •For AC220 (Quizartinib), Tosedostat and Ganetespib treatment the following criteria make a patient ineligible for that randomisation:
- •12.A myocardial infarction within 12 months
- •13.Uncontrolled angina within 6 months
- •14.Current or history of congestive heart failure New York Heart Association (NYHA) class 3 or 4, unless an echocardiogram (ECHO) or Multiple Gated Acquisition Scan (MUGA) performed either within 1 month prior to study screening or during screening results in a left ventricular ejection fraction (LVEF) that is greater than or equal to 45% (or institutional lower limit of normal value).
- •15.Diagnosed or suspected congenital long QT syndrome. Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, torsades de pointes [TdP]) or any history of arrhythmia will be discussed with the Clinical Coordinator/Safety Physician prior to patient’s entry into the study.
- •16.Prolonged QTcF interval on pre-entry ECG (greater than or equal to 450 ms)
- •17.Any history of second or third degree heart block (may be eligible if the patient currently has a pacemaker)
- •18.Heart rate less than 50/minute on pre-entry ECG
- •19.Uncontrolled hypertension
- •20.Obligate need for a cardiac pacemaker
- •21.Complete left bundle branch block
- •22.Uncontrolled atrial fibrillation
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